Feasibility Study of the Uriprene Stent Following Uncomplicated Ureteroscopy (URIPRENE)

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A prospective, single-center, single-arm, trial to demonstrate safety and device performance of the ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent. This is a first-in-man clinical study in a small human population.

Primary Objective: To assess the safety and feasibility of the Uriprene® Stent by assessing the time to complete degradation or the passage of stent fragments from the bladder by radiological assessment.

Composite of new-onset serious adverse event(s) including death, infection, the occurrence of surgery, re-hospitalization and or repeat hospitalization related to the device, or device related injury of the ureter.

Secondary Outcome Measures :

Technical Success [ Time Frame: 90 days ]

Technical success of the device defined as complete degradation of the stent within 90 days, as measured by radiology

Pain [ Time Frame: 90 days ]

Degree of comfort and pain as measured by the Pain, Symptom, and Satisfaction Questionnaire

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Ages Eligible for Study:

19 Years to 79 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients who are > 18, < 80 years of age; inclusive of males and females.